ewborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxide versus intravenous Sildenafil: ;an international randomized controlled trial

Phase 3

Recruiting

Conditions: High blood pressure in the lungs in patients with congenital diaphragmatic hernia
10027664

Registration Number: NL-OMON50767

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 45

Inclusion Criteria

• Diagnosis of CDH and pulmonary hypertension defined as 2 of the following 4
criteria: , I. PAP> 2/3 systemic pressure estimated by echocardiography ,
II. RV dilatation/septal displacement, RV dysfunction +/- LV dysfunction , III.
Pre-post ductal SpO2 difference > 10% , IV. OI>20. , • Parental informed
consent, • Children born at or after a gestational age of 34 weeks , • Newborns
who received a fetal intervention may be included

Exclusion Criteria

• Severe chromosomal anomaly, like trisomy 18 or trisomy 13, which may imply a
decision to stop or not to start life-saving medical treatment, • Severe
cardiac anomaly, expected to need corrective surgery in the first 60 days of
life (such as transposition of the great arteries, truncus arteriosus,
coarctation aortae or double outlet right ventricle), • Renal anomalies
associated with oligohydramnios, • Severe orthopaedic and skeletal deformities,
which are likely to influence thoracic, and / or lung development (such as
chest wall deformities and spine anomalies), • Severe anomalies of the central
nervous system, • iNO already started for postnatal transport

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is to determine if there is a difference in<br /><br>OI after 12 hours of treatment between CDH patients treated with iNO versus<br /><br>those treated with intravenous sildenafil. The OI is a calculated value to<br /><br>estimate severity of hypoxemic respiratory failure and is often used as a<br /><br>derivative for the severity of PH in newborns </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The presence/absence of pulmonary hypertension on day 14 without pulmonary<br /><br>vasodilator therapy and without treatment failure and/or death within the first<br /><br>28 days of life, overall mortality, treatment failure, time on study drug, need<br /><br>for ECMO, number of ventilator free days at day 28, severity of pulmonary<br /><br>hypertension, laboratory markers and tracheal aspirates for proteomic,<br /><br>metabolomics and biochemical analysis, the use of other medication given for<br /><br>pulmonary hypertension during the hospital admission, the use of pulmonary<br /><br>and/or cardiac medication at discharge, long-term pulmonary hypertension on<br /><br>echocardiography, chronic lung disease.</p><br>